Identity
- Trade Name
- SOBREPIN GOLA SPRAY IT EUDAMED
- Device Name
- SPRAY GOLA FAMILY EUDAMED
- Model / Reference
- FTPR12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056300621027 EUDAMED
- Basic UDI-DI
- 805630062FTPR1297 EUDAMED
- EMDN Code
- V9017 ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sobrepin Gola Spray It by Labomar S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805630062FTPR1297 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Labomar S.p.A.
- EUDAMED SRN
- IT-MF-000007965
Sources (1)
- EUDAMED 25e360e8-64c1-4637-adfc-224b22667a83 61 fields · synced Jun 18, 2026